The US giant, which last week issued a profit warning for next year, is basing its refiling for FDA approval on a new study. Even so, Vanlev is unlikely to reach blockbuster status in the near future: the earlier withdrawal has hit its physician credibility too hard. BMS needs another way to end its woes.

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Bristol-Myers Squibb [BMY] has just received FDA approval to market a novel HIV protease inhibitor, Reyataz. The launch of the once-daily drug will impact treatment strategies, and is likely to result in a shift of drug class dominance. BMS now needs to invest in additional clinical trials to target patients who are at later stages in their treatment.

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A large-scale trial in non-small cell lung cancer has found that Bristol-Myers Squibb's old platinum analogue, Platinol, is more effective than the company's newer and more profitable drug Paraplatin. The news, which confirms European physicians' suspicions concerning the two drugs, is yet another setback for BMS' troubled oncology portfolio.

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Despite the positive new results, Vanlev will have great difficulty gaining FDA approval for hypertension. Even if it is approved, establishing credibility with physicians will be harder still. In the current climate, concerns over side effects look almost certain to prevent Vanlev from reaching the blockbuster status BMS once expected.

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Erbitux (cetuximab), developed by ImClone [IMCL] and licensed to Bristol Myers Squibb [BMY] in the US, has been approved in combination with irinotecan by the FDA, after failing initial treatment with irinotecan. The approval comes at a time when BMS has been losing revenue due to several oncology patent expiries. This drug could help BMS regain its former position in the oncology field.

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Although this decision is unlikely to have a significant impact on Pravachol sales, it's still disappointing for BMS. It needs any revenue boost it can get this year, as sales of many of its other blockbuster drugs plummet. The FDA decision may also affect other players that plan to market single pills containing compounds for different indications, including Pfizer.

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The US FDA has approved a Supplemental New Drug Application for Bristol-Myers Squibb [BMY] and Otsuka Pharmaceuticals' dopamine antagonist Abilify (aripiprazole), for maintaining stability in patients with schizophrenia. This new indication is set to further boost Abilify's sales in an extremely competitive market, moving Abilify one step closer to blockbuster status.<BR />

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The FDA approval for BMS and Otsuka's Abilify should help atone for some of BMS' recent woes. The new drug, which has a superior side effect profile to any of its rivals, should see rapid uptake on launch. Despite competition from reformulations of existing drugs, Abilify should be a blockbuster drug - worth over $1.1 billion by 2010.

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Patients with peripheral vascular disease may be the greatest beneficiaries of new study findings, which demonstrate clopidogrel's cost-effectiveness, despite the drug's high price. Together with data supporting use in recent stroke patients, these results should help to better tailor clopidogrel to individual patient groups in the future.

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EU approval for the additional indication should follow within four months, making Aprovel the first AIIRB approved for such an indication and placing it at a significant advantage over the class leaders, Merck's Cozaar and Novartis' Diovan. However, BMS and Sanofi will have to submit more data to the FDA before they can gain the same advantage in the US.